PMCF Plan
PMCF Plan implementation varies among EU member states, and in general, PMCF related clinical trials can be performed after obtaining approval from relevant authorities in advance.
-
The PMCF Plan should specify the methods and procedures for collecting and evaluating data in advance, with the aim of :
- Continuously check the safety and performance of a medical device over its expected life
- Check for previously unknown side effects and monitor for identified side effects and bans
- Identifying and analyzing new risks through factual evidence
- Survey of acceptable benefits and risks
- Identify the possibility of device misuse and labeling to determine if the product is being used for the right purpose.
The PMCF plan should include the following :
- General methods and procedures for PMCF: clinical experience, feedback from product users, scientific literature, and other clinical materials
- Specific methods and procedures for PMCF: Appropriate registration, PMCF study
- Theoretical basis for the adequacy of methods and procedures used
- Clinical assessment report, risk management data
- Specific goals
- Clinical data evaluation data for equivalent or similar devices
- Related harmonization specifications and guidelines
- PMCF's Schedule
Services related to clinical investigation of DNA Technologies Pacific
The PMCF Plan should specify the methods and procedures for collecting and evaluating data in advance, with the aim of :